Dosivent

Organization name

Reiner Medtech S.L.U

SRN

ES-MF-000048477

Manufacturer status

Active

Primary placement in Spain; available across 11 countries total.

Trade name

Dosivent

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08437028850126

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

8437028850CIM1000000110HU

Reference / catalog number

00540ENA030

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://reinermedtech.es/

Clinical sizes

No clinical sizes registered for this device.

1 packaging level registered — each level carries its own UDI-DI.

• 08437028850126× 1 unitBase unit
  • 18437028850123× 10 units

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12159002AEROSOL EQUIPMENT

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.